B-Cell Acute Lymphoblastic Leukemia, Adult
Conditions
Keywords
CD19 CAR-T, CD22 CAR-T, Ph Chromosome Positive, B-ALL, Newly diagnosed
Brief summary
Clinical Trial for the Efficacy and Safety of Sequential CD19 and CD22 CAR-T Therapy for Adult Patients With Newly Diagnosed Ph Chromosome Positive B-cell Acute Lymphoblastic Leukemia
Detailed description
This study was designed as a prospective, open-label, single-center study. It aims to evaluate the efficacy and safety of CD19 CAR-T cells in combination with dasatinib for the treatment of newly diagnosed Ph-positive B-cell acute lymphoblastic leukemia in adult.
Interventions
Each subject receives sequential CD19 and CD22 CAR-T cells by intravenous infusion
Sponsors
Yake Biotechnology Ltd.
Zhejiang University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 years old; 2. Subjects with a diagnosis of B-cell acute lymphoblastic leukemia according to the 2016 edition of the WHO classification criteria for acute leukemia; 3. Subjects whose chromosomal and fusion gene analysis showed positivity for the Ph chromosome, BCR/ABL1 fusion gene; 4. Leukemia cells were CD19 and CD22 positive; 5. Patients with newly diagnosed B-ALL were not treated with standard chemotherapy regimens; 6. Serum total bilirubin ≤ 51 mol/L, serum ALT and AST both ≤ 3 times the upper limit of the normal range, blood creatinine ≤ 176.8 mol/L; 7. Echocardiography showed a left ventricular ejection fraction (LVEF) ≥50%; 8. Subjects had no active pulmonary infection and oxygen saturation ≥92% without oxygen; 9. The prognosis for survival is more than 3 months; 10. ECOG score 0-2; 11. Subjects volunteered to participate in this trial and signed an informed consent form.
Exclusion criteria
Subjects with any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete molecular response (CMR) rate | Up to 1 month after CAR-T cells infusion | Complete molecular response (CMR) rate after CD19 CAR-T cell therapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complete molecular response (CMR) rate | Up to 1 month after CAR-T cells infusion | Complete molecular response (CMR) rate after CD22 CAR-T cell therapy |
| Leukemia-free survival (LFS) | Up to 2 years after CD19 CAR-T cells infusion | From the complete remission to the occurrence of any event, including death, relapse (any one occurs first), and the last visit |
| Characterization of relapse | Through study completion, an average of 2 years | Including expression of CD19, CD22 and mutations in the ABL1 gene |
| cumulative incidence of relapse (CIR) | Up to 2 years after CD19 CAR-T cells infusion | From the complete remission to relapse |
| Incidence of treatment-emergent adverse events (TEAEs) | Through study completion, an average of 2 years | Incidence of treatment-emergent adverse events (Safety and Tolerability) |
| Overall survival (OS) | Up to 2 years after CD19 CAR-T cells infusion | From the first infusion of CD19 CAR-T cells to death or the last visit |
Countries
China
Outcome results
None listed